Status:
COMPLETED
A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid Arthritis
Lead Sponsor:
Centocor, Inc.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of infliximab (Remicade) in patients with early rheumatoid arthritis.
Detailed Description
This is a randomized, multicenter, double-blind, active-treatment-controlled, three-arm, parallel study of chronic treatment with infliximab. This study will determine whether infliximab, at two diffe...
Eligibility Criteria
Inclusion
- Diagnosis of rheumatoid arthritis for at least 3 months and less than or equal to 3 years before screening
- Active disease at the time of screening and pre-infusion of the drug
Exclusion
- Pregnant, nursing, or planning a pregnancy within 18 months of enrollment
- Incapacitated, largely or wholly bedridden, or confined to a wheelchair, or had little or no ability for self care
- Rheumatic disease other than rheumatoid arthritis or any current systemic inflammatory condition
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2003
Estimated Enrollment :
607 Patients enrolled
Trial Details
Trial ID
NCT00236028
End Date
April 1 2003
Last Update
May 19 2011
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